Conservative Texas judge weighs challenge to abortion pills

AMARILLO, Texas - A federal judge in Texas appointed by former President Donald Trump is considering a request by a Christian conservative group to overturn the Food and Drug Administration’s more than 2-decade-old approval of the abortion pill mifepristone.

The Alliance for Defending Freedom asked Judge Matthew Kacsmaryk on Wednesday for an immediate order that would revoke or suspend the drug's approval. Such a step would be an unprecedented challenge to the FDA, which approved mifepristone in combination with a second pill as a safe and effective method for ending abortion in 2000.

Lawyers for the FDA are expected to argue that pulling mifepristone from the market would upend reproductive care for U.S. women and undermine the government’s scientific oversight of prescription drugs.

Kacsmaryk has given each side two hours to argue their position in the high-stakes court case. Mifepristone’s manufacturer, Danco Laboratories, will join the FDA in arguing to keep the pill available.

A ruling could come any time after arguments conclude in the Amarillo court.

The hearing is the first in the case and is being closely watched by groups on both sides of the abortion issue in light of last year’s reversal of Roe v. Wade.

The Alliance for Defending Freedom was also involved in the lawsuit that led the Supreme Court to overturn Roe and return decisions on abortion to the states. Removing mifepristone from the market would curtail access to abortion even in states where it’s legal.

If Kacsmaryk rules against the FDA, it’s unclear how quickly access to mifepristone could be curtailed or how the process would work. The FDA has its own procedures for revoking drug approvals that involve public hearings and scientific deliberations, which can take months or years.

Mifepristone is part of a two-drug regimen that has become the most common method of abortion in the U.S. If mifepristone is sidelined, clinics and doctors that prescribe the combination say they plan to switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, though it is widely used in countries where mifepristone is illegal or unavailable.

The Texas lawsuit alleges that the FDA’s approval of mifepristone in 2000 was flawed for several reasons, including an inadequate review of the pill’s safety risks. The suit also challenges several later FDA decisions that loosened restrictions on the pill, including eliminating a requirement that women pick it up in person.

Lawyers for the FDA have pointed out that serious side effects with mifepristone are rare, and the agency has repeatedly affirmed the drug’s safety by reviewing subsequent studies and data. Pulling the drug more than 20 years after approval would be “extraordinary and unprecedented,” the government stated in its legal response.

A decision against the drug would be swiftly appealed by U.S. Department of Justice attorneys representing the FDA, who would also likely seek an emergency stay to stop it from taking effect while the case proceeds.

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